Ostomy appliance

ABSTRACT

A stoma adapter is described that is especially suited to a recessed stoma or a flush stoma. The stoma adapter effectively extends the discharge passage from the stoma, protects peristomal skin, and forms a bridge at the interface between the stoma and an ostomy appliance. The stoma adapter contains a substantially unobstructed discharge passage, at least for effluent flowing in a discharge direction. The stoma adapter includes a seal for sealing against the bowel wall. The stoma adapter has collapsing, expanding, flexible and reinforced designs.

FIELD OF THE INVENTION

The present invention relates to an ostomy appliance. In particular, theinvention relates to an ostomy appliance having a stoma adapter, and toa stoma adapter for an ostomy appliance.

BACKGROUND TO THE INVENTION

The creation of an ostomy (stoma) is the therapy for many sufferers ofdisease or injury of the gastrointenstinal or urinary tract. An ostomyis a rerouting of the tract through an opening or stoma in the abdominalwall to the outside of the body. The term “ostomy” typically includescolostomy, ileostomy and urostomy. Once this opening has been created,the patient must use an ostomy appliance attached to their body by somemeans to capture or manage the body waste. This is typically done with adisposable ostomy pouch that is attached to the patient's peristomalarea by means of an adhesive. A typical ostomy appliance consists of anostomy pouch and an adhesive body fitment. In some examples, the pouchand body fitment are separate components whereby a replacement pouch canbe removably attached to the body fitment while the same body fitmentremains attached to the body at the stoma site. In other examples, thepouch and the body fitment are permanently attached together, and areapplied to and removed from the stoma site as an integral unit.

Ideally, the stoma should protrude from the abdominal surface of theostomate by a distance ranging from 0.5 cm to 2.5 cm. This protrusionforms a spout, from which effluent can discharge directly into thepouch. However, in many cases, the stoma protrudes by a lesser amount ornot at all. For example, a “flush stoma” is a condition when the stomareaches only as far as the surface of the abdomen; a “recessed stoma” isa condition when the stoma does not even reach the surface of theabdomen, and the peristomal skin is drawn into a funnel shaped mouthbetween the stoma and the abdominal surface. There are many potentialcauses for these conditions. These can include formation of the stomawith little or no protrusion by the surgeon; and post-operative weightgain by the ostomate. Post-operative weight gain causes the ostomate'sabdominal region to expand in girth while the length of the intestineattached to the abdomen remains fixed, thereby resulting in the stomabeing pulled toward and ultimately below the surface of the abdomen.

Flush and recessed stomas can be difficult to manage, because someeffluent discharged from the stoma can tend to pool around the stoma,instead of the effluent discharging completely into the pouch. Stoolretained in this manner can attack the interface between the adhesivebody fitment and the ostomate's peristomal skin. Such attack reduces theadhesion of the body fitment to the skin, thereby reducing theeffectiveness and the usable life of the appliance. The stool can alsocause irritation and degradation of the peristomal skin itself. Stoolexiting the stoma may contain digestive juices from the body, and suchjuices can attack the peristomal skin resulting in excoriation.

One current technique for dealing with a flush stoma and/or a recessedstoma is to use a body fitment with a convex pressure plate to applyincreased local pressure to the skin immediately adjacent to the stoma.The increased pressure protrudes the stoma slightly, but a strongadhesion of the body fitment to the peristomal skin may be required tobear the reaction force.

U.S. Pat. No. 6,033,390 describes a continent ostomy port that includesa tube inserted into the stoma, and a closure for selectively closing adischarge channel within the tube. This device is for general stomas,and does not address the problem of recessed or flush stomas. A primaryfunction of the device is to act as a controllable closure, for blockingdischarge of effluent when desired by a user. However, the existence ofthe closure means that the tube inserted into the stoma has to form astrong seal against the stoma tissue, in order to withstand the pressureof effluent backing up inside the intestine, and to prevent sucheffluent from leaking between the stoma tissue and the inserted tube.

It may be desirable to provide an alternative technique for a flushstoma and/or a recessed stoma.

SUMMARY OF THE INVENTION

The present invention provides a stoma adapter for at least partialinsertion into a stoma and/or into a peristomal mouth surrounding arecessed stoma.

The stoma adapter may be configured as one or more of the following:

-   -   (a) A stoma extension, for extending the discharge passage in a        stoma to a location external of the stoma, in order to deliver        effluent to a point relative to the ostomy appliance from which        the effluent can more directly discharge into the interior of        the appliance than were the adapter not present.    -   (b) A stomal effluent diverter, for diverting or directing        effluent exiting the stoma away from contact with peristomal        skin and/or away from contact with an edge of the skin adhesive        of an adhesive body fitment.    -   (c) A liner for protecting peristomal skin, and/or an edge of        the skin adhesive of an adhesive body fitment, from contact with        stoma effluent. The liner may extend into the interior of the        stoma as a stoma liner.

The stoma adapter is especially suitable for a flush stoma or a recessedstoma, but is not limited thereto.

In one form, the stoma adapter extends closer to the stoma than does theskin adhesive of the adhesive body fitment.

In one form, the stoma adapter may be separate from the body fitment ofan ostomy appliance. In another form, the stoma adapter is releasablyattached to the body fitment, for example, by an adhesive coupling or amechanical interference coupling. In yet another form, the stoma adapteris permanently secured to the body fitment as an integral part.

In one form, the stoma adapter is elongate and/or tubular. The stomaadapter may include a discharge passage that is longer than at least theminimum transverse dimension (and optionally longer than the maximumtransverse dimension).

In one form, the stoma adapter (at least once fitted to a stoma) definesa substantially unobstructed discharge channel for effluent dischargingfrom the stoma. The stoma adapter may be referred to as a free-flowstoma adapter (and/or a free-flow diverter). The stoma adapter may bepermanently open. In another form, the stoma adapter includes a valve.The valve is openable under pressure of effluent when the bowel forcesthe expulsion of effluent. The valve does not block stomal discharge,but merely provides a partial closure to avoid the stoma beingpermanently open. The valve could be a one-way valve, to avoid entry ofexternal matter into the stoma.

Making the discharge channel substantially unobstructed for stomaldischarge reduces the stress to which the seal between the stoma adapterand the stoma tissue will be subject in use, compared to the seal stressof a continent ostomy port with a permanent tube having a closabledischarge channel. With less seal stress to withstand, the stoma adaptercan be configured to engage the stoma tissue much more lightly andgently than a continent ostomy port.

In effect the functions of the stoma adapter of the present inventionand a continent ostomy port are quite contrary. The continent stoma portseeks to provide a firm engagement against the stoma tissue to provide areliable closure that prevents stoma discharge; whereas the presentinvention seeks to provide a minimum engagement against the stoma, inorder to provide a substantially unobstructed discharge channel thatdelivers stomal discharge away from the peristomal skin.

It should be noted for the purpose of clarity that, in this document,“proximal” refers to an object, feature, or general direction toward theinside of the body. “Distal” refers to an object, feature, or generaldirection toward the outside of the body.

Accordingly, the present ostomy device has a stoma adapter that directsstomal effluent from the bowel into a collection pouch. The devicecovers the peristomal skin and the interface between the skin and theostomy appliance. The device can be partly or fully inserted into thestoma. It also may be an open-ended tube. The tube can be rigid. Anotherpossible form is that it is partially deformed by forces applied by thebowel, but remains open throughout its length.

The tube thickness can be in the range of 0.0001 inch to 0.20 inch. Thetube can be reinforced so as to provide stiffness in the axial directionwhile permitting flexure in the radial direction. An example ofreinforcement is an array of longitudinal elements located around thecircumference of the tube and which are oriented generally parallel tothe axis of the tube, wherein the largest cross-section dimension ofeach element is less than 10% of the largest cross-section width of thetube.

Option for reinforcement elements include: a hollow cross-section,inflatability, flexible material composition, formation of elements byselectively attaching multiple layers of the tube wall together to forma hollow cavity, a helical compression spring attached to or imbedded inthe tube. The compression spring may, for example, be composed ofresilient material or of a hollow tube having no intrusive resiliencebut becomes resilient when inflated.

Reinforcement can also be accomplished with a pattern of selectivecoating on the tube to locally modify its properties and wherein theresult of this pattern is an increase in axial stiffness of the tube.

The tube may have other properties such as being at least partiallycollapsed in cross-section to reduce its cross-sectional width whereinthe tube can subsequently expand to its final cross-sectional shape.Others include wherein the tube is bistable and retains its folded shapeuntil it is deliberately expanded or wherein the tube is held in itsfolded shape by a retaining member.

It is possible to have a tube that is sufficiently flexible that itsbore can be closed by forces applied by the bowel.

Example of a retaining member shapes includes generally cylindrical, orconical. The retaining member may be of the type that may be broken ordissolved to allow the tube to expand. The retaining member can beremoved off of the proximal or distal end of the tube.

Dissolution of the retaining member can be accomplished by forming thedevice of one or more water soluble polymers such as polysaccharides,cellulosics such as hydroxypropylmethyl cellulose, hydroxyethylcellulose, hydroxypropyl cellulose, carboxymethyl cellulose, chitosanand its derivatives, gelatin, alginates, sodium alginate, xanthan gum,tragacantha, guar gum, acacia gum, arabic gum, polyacrylic acid and itscopolymers, polypeptides, sulfonated polymers, polyacrylamide and itscopolymers, polyvinyl pyrrolidone, polyvinyl ether, polyvinyl alcohol,polyethylene, glycol, methylmethacrylate copolymers, carboxyvinylpolymers and copolymers.

The device may be formed, for example, from one or more of the followingmaterials: cellulosic polymers, alginates, chitosan and its derivatives,polyesters, polyacrylonitriles, polyolefins, diene elastomers,polyamides, polyurethanes, polyethers, polyvinyl alcohol, polyetherblock amides, polyimides, silicones, polyacrylates, polymethacrylates,ionomers, polyvinylacetate and its copolymers, polyvinylchloride,polyvinylidene chloride, or fluorinated polymers.

Ways of forming the stoma adapter include injection molding,thermoforming, blow molding, casting, extrusion or fabrication formsheet stock.

The proximal portion of the device seals against the inner bowel wallfor at least part of its length. The distal end of the device may beattached to and seal against the wearer's peristomal skin. Also, thedistal end of the device may be attached to and seal against theproximal side of the ostomy wafer and the distal surface of the ostomywafer.

The stoma adapter may be partly retained in place by an attachment atits distal and/or proximal end. Different ways of attaching or retainingthe distal end include utilizing an adhesive bond, a solvent bond, aheat weld, an ultrasonic weld, a radio frequency weld, a laser weld, amechanical interference, or a mechanical snap ft. Retention of theproximal end can be achieved with material that includes an adhesive gelor coating that adheres the seal to the inner bowel wall. The materialcan be coated onto the seal prior to insertion or it can be dispensedfrom the seal after the device has been introduced into the bowel.

The seal is formed from a resilient polymer, elastomer or foam that isat least partly plastically deformable. The seal may have an annularshape. The seal can be created at the proximal end of the device.

The seal may be an expanding inflatable volume formed from a flexiblematerial, such as a film. The seal inflation material may be a gas,liquid or gel.

The seal material may include a resilient foam member and may cause theseal to inflate.

In certain forms, the device can be inserted directly into the stoma.Another possible way to insert a flexible stoma adapter is to partiallyinvert it one or more times along its length so that the device can beintroduced into the stoma by temporarily closing the proximal end andpressurizing the distal end.

Additional features and/or aspects of the invention are defined in theclaims and/or apparent from the following description. Although certainfeatures have been highlighted above and in the appended claims, claimprotection may be sought for any inventive feature and/or idea describedherein and/or illustrated in the drawings, whether or not emphasis hasbeen placed thereon.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic sectional view through a first embodiment of stomaadapter.

FIG. 2A is a schematic perspective view of a second embodiment of stomaadapter.

FIG. 2B is a schematic sectional view showing the second embodiment inuse.

FIG. 3A is a schematic sectional view through a third embodiment ofstoma adapter.

FIG. 3B is a magnified view showing a detail of FIG. 3A.

FIG. 4A is a schematic sectional view through a fourth embodiment ofstoma adapter.

FIG. 4B is a magnified view showing a detail of FIG. 4A.

FIG. 4C is a sectional view of the fourth embodiment showing the distalend extending beyond the attachment plane of the body fitment.

FIG. 5 is a schematic perspective view of a fifth embodiment of stomaadapter

FIG. 6 is a schematic sectional view through a sixth embodiment of thestoma adapter.

FIG. 7 is a schematic sectional view showing deployment of the sixthembodiment.

FIG. 8A is a schematic sectional view through a seventh embodiment ofstoma adapter.

FIG. 8B is a schematic perspective view of the seventh embodiment.

FIG. 9A is a schematic perspective view showing the proximal end of aneighth embodiment of stoma adapter.

FIG. 9B is a schematic sectional view through the proximal end of theeighth embodiment.

FIG. 10A is a schematic sectional view through a ninth embodiment ofstoma adapter in use.

FIG. 10B is a schematic section through the ninth embodiment inisolation.

FIG. 10C is a sectional view of the ninth embodiment showing anexpandable foam element within an inflatable bolster.

FIG. 11 is a schematic section through a tenth embodiment of stomaadapter.

FIG. 12A is a schematic sectional view showing an eleventh embodiment ofstoma adapter in use.

FIG. 12B is a schematic sectional view showing an eleventh embodiment ofstoma adapter in use.

FIG. 12C is a schematic sectional view showing an eleventh embodiment ofstoma adapter in use.

FIG. 12D is a magnified view of a detail of FIG. 12C.

FIG. 13A is a schematic perspective view of a twelfth embodiment ofstoma adapter.

FIG. 13B is a schematic diagram illustrating flexing of the twelfthembodiment in use.

FIG. 13C is a schematic diagram illustrating flexing of the twelfthembodiment in use.

FIG. 14A is a schematic perspective view of a thirteenth embodiment ofstoma adapter.

FIG. 14B is a magnified view of a detail of FIG. 14A.

FIG. 15A is a schematic perspective view of a fourteenth embodiment ofstoma adapter.

FIG. 15B is a schematic perspective view of a fifteenth embodiment ofstoma adapter.

FIG. 15C is a schematic perspective view of a fifteenth embodiment ofstoma adapter.

FIG. 16A is a progression of end-section views showing deployment of asixteenth embodiment of stoma adapter.

FIG. 16B is a progression of end-section views showing deployment of aseventeenth embodiment of stoma adapter.

FIG. 17 is a schematic perspective view showing use of an applicator foraiding insertion of a stoma adapter into the stoma.

FIG. 18 is a schematic side view of an eighteenth embodiment of stomaadapter.

FIG. 19A is a schematic side view of a nineteenth embodiment of stomaadapter.

FIG. 19B is a schematic side view of a nineteenth embodiment of stomaadapter.

FIG. 20A is a schematic sectional view showing insertion and deploymentof a twentieth embodiment of stoma adapter.

FIG. 20B is a schematic sectional view showing insertion and deploymentof a twentieth embodiment of stoma adapter.

FIG. 20C is a schematic sectional view showing insertion and deploymentof a twentieth embodiment of stoma adapter.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring to the drawings, the same reference numerals are used todepict the same or similar features. The features of the followingembodiments may be combined as desired; the separate description offeatures as different embodiments is mainly to ease clarity, and doesnot in any way mean that certain features should not or cannot be usedtogether.

Referring to FIG. 1, a recessed stoma 10 is illustrated, in which thestoma 10 is joined to the peristomal skin 12 at a point 14 that isslightly below the abdominal skin level 16. A most basic form of stomaadapter 20 comprises, or is in the form of, a tube having a proximal end22 inserted into the stoma 10 and into the funnel shaped mouth definedby the peristomal skin around the recessed stoma 10, at least to thelevel of the stoma 10. The stoma adapter 20 has a distal end 24 thatprojects beyond the abdominal skin level 16. The distal end 24 mayoptionally be angled to direct stomal discharge downwardly, if desired.The distal end 24 projects at least partly into the entrance aperture 26of an ostomy appliance 28 comprising a collection pouch 30. The ostomyappliance 28 is secured to the peristomal skin 12 by means of anadhesive body fitment 32 comprising or consisting of an adhesive wafer.The ostomy appliance 28 may be a one-piece appliance in which the bodyfitment 32 is permanently attached to the pouch 30, or it may be atwo-piece appliance in which the pouch 30 may be releasably attached tothe body fitment 32 by means of a releasable coupling (not shown) suchas an adhesive coupling or a mechanical interference coupling.

The stoma adapter 20 defines a free-flow, substantially unobstructed,passage 34, to deliver stomal discharge from the proximal end 22inserted at the stoma 10, to the distal end 24 projecting into theentrance aperture 26 of the ostomy appliance 28. The stoma adapter 20thus closely approximates the function of a stoma with an “ideal”protrusion from the peristomal skin. The stoma adapter 22 functions as astoma extender and/or a stoma effluent diverter and/or a stoma liner.The stoma adapter 20 diverts stomal discharge away from the peristomalskin 12, directly into the interior of the ostomy appliance 28. Bykeeping the stomal discharge clear of the peristomal skin 12: (i) therisk of the effluent attacking the adhesion between the body fitment 32and the peristomal skin 12 is reduced, thereby leading to better productlife; and/or (ii) the risk of irritation or excoriation of theperistomal skin 12 is very much reduced.

The stoma adapter 20 may be relatively short, such that the proximal end22 does not extend very far into the stoma 10 (or even is insertedmerely to the point 14 at which the stoma 10 meets the peristomal skin12). Alternatively, the stoma adapter 20 may be relatively long suchthat it extends more substantially into the stoma 10. The stoma adapter20 preferably defines a discharge passage 34 that has a longitudinal(axial) dimension that is greater than a minimum transverse dimension(or more preferably greater than a maximum transverse dimension).

The stoma adapter 20 may be permanently open, to define the free-flowdischarge passage 34. Alternatively, the stoma adapter 20 may comprise avalve (depicted generally by the numeral 36). The valve 36 may bedisposed at any desired location, for example, at the proximal end 22 orthe distal end 24, or intermediate the two. The valve 36 may beconfigured as a closed end of the tube. The valve 36 is configured notto obstruct the discharge of effluent, and is configured to open underthe pressure of effluent when the bowel forces the expulsion ofeffluent. The valve 36 may be a one-way valve.

In the embodiment of FIG. 1, the stoma adapter 20 is generallyindependent of the ostomy appliance 28 and the body fitment 32.

FIGS. 2a and 2B illustrate a second embodiment in which the distal end24 of the stoma adapter 20 comprises a shoulder or flange 38. The flange38 acts as a stop to limit the degree of insertion of the stoma adapter20 into the stoma 10. In the present embodiment, the flange 38additionally is dimensioned to engage the body fitment 32. For example,the flange 38 is slightly larger in diameter than the entrance aperture26 in the adhesive body fitment 32. The flange 38 is configured toengage the rear surface (in FIG. 2B) or alternatively the front surface(not shown) of the body fitment 38. For a one-piece appliance, the stomaadapter 20 can be inserted at the stoma 10 before the body fitment 32 ofthe ostomy appliance 28 is attached to the peristomal skin 12, such thatthe periphery of the flange 38 is trapped between the skin 12 and thebody fitment 32 to hold the stoma adapter 20 positively in position.

FIGS. 3A and 3B shows a modified third embodiment similar to the secondembodiment, except for the following refinements:

The flange 38 is implemented with a rounded funnel shape that joins thetubular portion of the stoma adapter 20 to define a smoothly roundedtapering profile.

The flange 38 is releasably or permanently attached to the body fitment32, at a point of attachment indicated generally by numeral 40. Thepoint of attachment 40 may on the distal (front) surface of theadhesive. Such a configuration provides direct transport of effluentfrom the bowel into the pouch, bypassing peristomal skin 12 between thestoma 10 and the inner edge of the adhesive wafer of the body fitment32. It also bypasses the interface between the peristomal skin 12 andthe body fitment 32. Attachment between the stoma adapter 20 and thebody fitment 32 may be accomplished by a variety of means, includingadhesive bonding, solvent bonding, and welding (e.g., heat welding,ultrasonic welding, laser welding, or radio frequency welding). Theattachment point 40 may also be adhesive attachment using the adhesionof the skin adhesive in the body fitment 32. In the case of any of theadhesive types of attachment, the attachment may be permanent orreleasable (e.g., peelable) as desired.

FIGS. 4A and 4B show a modified fourth embodiment similar to the secondand third embodiments, except the fourth embodiment uses a mechanicalfastener 42 to join the distal end 24 of the stoma adapter 20 to thebody fitment 32. The mechanical fastener 42 comprises mating rings 44and 46 on the body fitment 32 and the stoma adapter 20. For example, thering 46 of the stoma adapter 20 may form a snap fit behind the ring 44on the body fitment 32, to be trapped between the body fitment 32 andthe peristomal skin 12. The mechanical fastener 42 may be releasablewhile the body fitment 32 remains in place on the peristomal skin 12, orthe fastener 42 may be configured as non-releasable (e.g., at leastuntil the body fitment 32 is removed). The mechanical fastener 42 may beaugmented by an adhesive attachment (indicated between the parts at 48)and/or seal that would also provide an adhesive connection between thestoma adapter 20 and the body fitment 32.

Also, in the fourth embodiment, the stoma adapter 20 generally has amore conic shape, at least towards the distal end 24, so that the flangeis less pronounced.

As seen in FIGS. 4B and 4C, the distal end 24 of the stoma adapter 20may extend out past the stoma 10 and then return to attach to the bodyfitment 32. Such a shape would allow the stoma adapter 20 to moveaxially with the stoma 10 without placing unwanted stress on theattachment to the body fitment 32.

Formation of the stoma adapter 20 can be accomplished by a variety ofmethods. These include, but are not limited to, injection molding, blowmolding and longitudinal seal bonding of flat sheet material to form atube. The tube material may or may not, as desired, have gas barrierproperties to contain or manage odor. The stoma adapter 20 material mayor may not, as desired, have properties that reduce the friction ofeffluent flow along its length, in order to promote easier discharge ofeffluent. The stoma adapter 20 may or may not, as desired, haveproperties that improve ease of introduction into the bowel. Theseproperties may be imparted by the material itself, by impregnating thematerial with specific additives intended to impart those properties tothe material, or by application of one or more coatings to theappropriate surface(s) of the stoma adapter 20.

The preferred cross-sectional shape of the stoma adapter 20 in theembodiments is circular, but in some cases, it may be desirable for thestoma adapter 20 to have a conic, but non-circular shape. It may also bedesirable for the stoma adapter 20 to have a cross-sectional shape thatclosely approximates the shape of the inner surface of the bowel toensure that it conforms to the bowel along the full length of the stomaadapter 20. This may be accomplished by creating a custom shape for eachstoma adapter 20 to match the wearer. It may also be accomplished byimparting elastic properties to the stoma adapter 20 that cause it todeform to match the shape of the bowel after introduction. These changesmay be purely elastic, in which the stoma adapter 20 regains itsoriginal shape after removal. Or, the changes may be entirely plastic,in which the adapter 20 retains the shape of the inner surface of thebowel. Or, the changes may be a combination of elastic-plastic behavior,in which the stoma adapter 20 partially retains the shape of the bowelafter removal. Materials for such a stoma adapter 20 include, but arenot limited to, biocompatible materials of natural or synthetic origin,such as olefin plastics, polycarbonates, styrenes, flouropolymers,thermoplastic elastomers, polyurethanes, polyesters, cellulose polymers,alginates, chitosan and its derivatives, polyacrylonitriles, dieneelastomers, polyamides, polyethers, polyvinyl alcohol, polyether blockamides, polyimides, silicones, polyacrylates, polymethacrylates,ionomers, polyvinylacetate and its copolymers, polyvinylchloride,polyvinylidene chloride, and fluorinated polymers. Compositeconstruction including one or more of the above and/or metallic elementssuch as springs, may also be desirable. Shape memory metals or polymersmay be suitable for the shape recoverable embodiments illustrated later.Methods of formation of such a stoma adapter 20 may include, but are notlimited to, any of injection molding, thermoforming, extrusion, casting,blow molding, sterolithography, or fused deposition, or selective lasersintering.

The properties of the stoma adapter 20 may vary depending on the designand the intended application. For example, a rigid stoma adapter 20 (asin the first to third embodiments) may be useful for holding the bowelopen and to maintain a constantly open flow path for efficientlydirecting effluent from the bowel.

Alternatively, the stoma adapter 20 may be formed of thin, flexiblematerial such a plastic film (as in the fourth embodiment, and a fifthembodiment illustrated in FIG. 5). The flexible material may or may nothave elastic properties, as desired. Use of a flexible material may besuitable for where compatibility with natural movements of the bowel isdesired. The bowel typically changes its cross-sectional shape as aresult of a variety of conditions. These include normal peristalticmotion, flexure of the abdominal wall, vigorous physical activity, andthe passage of effluent through the bowel. A stoma adapter 20 made fromthin, flexible material may be used where it is desired to presentlittle or no hindrance to natural motion of the bowel.

A further aspect of the stoma adapter 20 is the creation of a sealbetween the bowel wall 52 and the stoma adapter 20. The followingembodiments illustrate certain seal principles. Although theseembodiments illustrate seal features separately, the sealingarrangements may be combined, and any of the seal arrangements may beused with any of the preceding embodiments.

Referring to FIGS. 6 and 7, in a further embodiment, the proximal end 22of the stoma adapter 20 incorporates a seal 50 between the inner surfaceof the bowel wall 52 and the outer surface of the stoma adapter 20.Because the stoma adapter 20 is configured not to obstruct the free flowof effluent in the discharge direction, and is not intended to be closedor to block flow, the intent of the seal 50 is merely to divert the flowof effluent into the stoma adapter 20 (as indicated by arrows 54). Theseal 50 does not have to withstand the pressure of effluent backing upinside the bowel. In the preferred embodiments, the seal 50 performs thefunction of flow diversion with a minimum level of pressure exerted onthe bowel tissue. It is desirable to create a seal that conforms to thelocal shape and topography of the inner surface of the bowel wall 52.

In the embodiment of FIGS. 6 and 7, the seal 50 is provided by a bolster56. The bolster 56 is optionally inflatable to expand into seal contactwith the inner surface of the bowel wall 52. Inflation fluid may besupplied from an external source 58 through an inflation capillarychannel (not shown). The inflation pressure would be a minimum requiredto create an effective seal, to ensure that blood flow through the boweland to local seal contact area would not be compromised.

Referring to FIGS. 8A and 8B, in a further embodiment, the seal 50comprises two (or more) distinct inflatable sealing elements or bolsters56. The bolsters 56 are radially and/or axially displaced from eachother. The bolsters 56 may be inflated to the same inflation pressure,or different inflation pressures. The bolsters 56 may be inflated from acommon inflation port (optionally, with some inflation pressureregulator if the bolsters 56 are to be inflated to different inflationpressures), or from independent inflation ports to allow completecontrol over each respective inflation pressure. Two or more bolsters 56may be desirable in certain applications.

With the embodiments of FIGS. 6-8, the inflation fluid may be a gas(such as air) or a liquid (such as saline), or a gel, or any suitablefluid that can be transferred from one volume to a second volume toexpand the second volume. The inflation fluid may retain its properties,or it may set into a rigid or semi-rigid state after filling theinflatable bolster 56.

Referring to FIGS. 9A and 9B, the inflation fluid could be or comprise asealant material. Furthermore, the bolster 56 may be configured topermit the sealant to pass through the wall(s) of the bolster 56 to forma seal between the bolster 56 and the bowel wall 52. For example, thebolster 56 may have small (e.g., microscopic) holes 66 in specific areasthat contact the bowel wall 52, in order to preferentially pass thesealant 62 (as indicated by arrows 60) to the corresponding region ofthe bowel wall 52, to fill any gaps (indicated by the sealant filling 62in FIG. 9B).

Referring to FIGS. 10A and 10B, instead of an inflatable bolster 56, thestoma adapter 20 comprises an annular foam ring 64 to contact the innersurface of the bowel wall 52 and create a seal. The foam ring 64 isoptionally shaped to improve its sealing properties. The thickness ofthe foam, and/or the diameter of the foam, and/or the contact angle ofthe foam can also be adjusted to optimize the sealing characteristics.In the illustrated embodiment, the foam ring has a conical shape,presenting a funnel-like geometry to the flow of effluent. The innerand/or outer surface may be frusto-conical. Other shapes of foam ring 64could be used as desired. For example, the foam ring could alternativelyhave a cylindrical annular shape, whose cross section is orientedgenerally perpendicular to the surface of the inner bowel wall 52.

The properties of the foam may also be adjusted to improve theproperties of the seal. The foam may be open or closed cellconstruction, depending on the requirements of the application. Elasticproperties of the foam could be adjusted to ensure the proper balancebetween sealing pressure and seal performance.

Referring to FIG. 10C, the bolster 56 may enclose a expanding foamelement 68. The preferred embodiment of the foam element 68 r is anannular ring, although other symmetrical or non-symmetrical shapes maybe preferred for specific applications. The natural tendency of the foamelement 68 to expand would inflate the bolster 56 and cause it toconform to the size and shape of the bowel wall 52. As the foam element68 expands, air or any other suitable inflation fluid would be drawninto the bolster 56.

It is possible to control the response of the foam-filled bolster 56 bycontrolling the rate at which inflation fluid enters and exits thebolster 56. This response could include, but not be limited to,inflation with little or no flow restriction and deflation with a highflow restriction.

Referring to FIG. 11, in another embodiment, one or more elastomericrings 66 located at the proximal end 22 of the stoma adapter 20 serve tohold the proximal end 22 of the tube in sealing contact with the innersurface of the bowel wall 52. Two or more of these elastometric rings 66could be axially displaced along the tube of the stoma adapter 20. Theelastometric rings 66 may optionally be of different diameters, toimprove the adapter's ability to effectively seal against a surface thatis different in size from one ostomate to another, and which may changein size continually.

Referring to FIGS. 12A, 12B, 12 c and 12D, in another embodiment, theproximal end 22 of the stoma adapter 20 is plastically deformable. Inuse, when inserting the stoma adapter 20 into the stoma 10, the proximalend 22 is stretched circumferentially until it achieves conformalcontact with the inner surface of the bowel wall 52. Stretching of theproximal end 22 of the stoma adapter 20 could be achieved by means of aninflatable bolster 56 which would be removed after creation of the seal50. The function of the seal 50 could be enabled or enhanced by theapplication of a sealant or an adhesive (region 70) to the contact areaof the seal before introduction or during manufacture.

Another aspect of the stoma adapter 20 is retention in the stomaand/bowel. The following embodiments illustrate various retentionprinciples. Although these embodiments illustrate retention featuresseparately, the retention arrangements may be combined, and any of theretention arrangements may be used with any of the precedingembodiments.

In some applications, retention of the stoma adapter 20 in the bowel issignificant for its function. In the case of a rigid or semi-rigid stomaadapter 20, then it is possible to ensure retention of the proximal end22 in the bowel by anchoring the stoma adapter 20 externally to thebowel. For example, attaching the distal end 24 of the stoma adapter 20to the distal surface of the body fitment 32, to the pouch 30, ordirectly to the ostomate's peristomal skin 12 could achieve thatanchoring function (as illustrated in FIGS. 3a , 3B, 4A and 4B).

In the case of a stoma adapter 20 that is constructed wholly orpartially of thin, flexible material, it may be desirable to prevent thestoma adapter 20 from collapsing along its axis due to peristalticforces or the force of expelled effluent. One method of ensuringretention of a flexible tubular stoma adapter 20 is to reinforce it inthe axial direction without adversely affecting its ability to conformto the inner surface of the bowel wall 52. The axial stiffness supportsthe proximal end 24 of the stoma adapter 20 in the same way that a rigidor semi-rigid stoma adapter.

Referring to FIGS. 13A, 13B and 13C, one means of providing axialstiffness to incorporate a multiplicity of buttress or reinforcingelements 72 on the outer or inner surface of the stoma adapter 20. Thereinforcing elements 72 are oriented generally parallel to the tubularaxis of the stoma adapter 20. The size, number, and placement of thereinforcing elements 72 would determine the axial stiffness of the stomaadapter 20. However, because the individual reinforcing elements 72 arerelatively compliant in the transverse direction, the tubular stomaadapter 20 would remain radially flexible (see arrows 74 a indicatingflexing in the radial direction when squeezed; and arrows 74 brepresenting withstanding of an axial force).

Referring to FIGS. 14A and 14B, in another embodiment of this axialbuttress or reinforcement approach, the surface of the stoma adapter 20includes a multiplicity of tubes 76 (flexible capillaries) runninglength of the stoma adapter 20. These tubes 76 are smaller in crosssection than the main discharge passage 34 of the stoma adapter 20, withcross section widths less than 25% of the cross section width of thedischarge passage 34. These tubes 76 can be formed from very softmaterial. In one form, the tubes 76 are additional components assembledto the stoma adapter 20; in another form, the tubes 76 are integrallyformed as part of the structure of the stoma adapter 20 itself. Forexample, the smaller tubes 76 are formed by selectively attachingtogether portions of adjacent layers 78 a, 78 b of the material formingthe multi-layer wall 78 of the stoma adapter 20. In use, inflation ofthe tubes 76 imparts axial rigidity to them, and therefore to the stomaadapter 20. At the same time, the tubes 76 are compliant to local radialforces. The smaller tubes 76 could be inflated from the same source asthat used to inflate a proximal seal 50, or they may be inflated by aseparate source, either after introduction into the bowel, duringintroduction, or before introduction.

Referring to FIGS. 15a , 15B and 15C, in another embodiment, a helicalspring 80 is used to impart an appropriate level of resistance to axialforce while allowing a high level of radial compliance. In one form(FIG. 15A), the spring 80 is mechanical in nature; that is, formed froman elastic material such as a metal or polymer. In another form (FIGS.15B and 15C), the spring 80 is formed from a flexible tube 82 with ahelical shape. The flexible tube 82 is attached to or incorporated intothe stoma adapter 20 in the same manner as the tubes 76 of FIGS. 14A and14B. The flexible tube 82 would have no intrinsic strength when notinflated (FIG. 15B). When inflated (FIG. 15C) to a desired inflationpressure through inflation port 84, the flexible tube 82 exhibits thedesired level of axial stiffness yet maintaining radial compliance.

In another embodiment (not shown), longitudinal buttress or reinforcingelements could be made of a material with different physical propertiesthan the main tube of the stoma adapter 20. Such reinforcing elementscould, for example, be incorporated into the stoma adapter 20 byco-extrusion.

In another embodiment (not shown) the axial stiffness of the stomaadapter 20 could be enhanced by selectively coating the stoma adapter 20in specific areas with materials that modify the properties of the tube76, 82 by either imparting their own stiffness to enhance the stiffnessof the entire structure or by locally modifying the properties of thestoma adapter 20 material itself.

Another aspect of the stoma adapter 20 is insertion in the stoma 10and/bowel. The following embodiments illustrate various insertionprinciples. Although these embodiments illustrate insertion featuresseparately, the insertion arrangements may be combined, and any of theinsertion arrangements may be used with any of the precedingembodiments.

If the stoma adapter 20 is rigid, or at least semi-rigid, introductionof the proximal end 22 into the bowel is likely to require a degree ofradial stretching or compliance of the bowel at one or more locationsalong the length of the stoma adapter 20. FIGS. 16A and 16B illustratean idea of collapsing cross-section configurations that may be employedto minimize (or at least reduce) the amount of compliance or stretchingof the bowel during introduction of the stoma adapter 20. By creating abistable cross section 88, it is possible to more easily introduce theproximal end 22 of the stoma adapter 20 in its collapsed configuration,and then expand it to its final configuration after insertion. In oneembodiment (FIG. 16A), the collapsed configuration of the stoma adapter20 is, in cross section, two adjacent semi-circular shapes 90 a and 90b. Upon insertion, the stoma adapter 20 is expanded by driving out theinner semi-circular shape 90 b until the stoma adapter expands, in crosssection, into a complete loop 92 (e.g., circle) after introduction. Inanother embodiment (FIG. 16B), the collapsed configuration of the stomaadapter 20 has a fluted cross section, with flute segments or channels94 that give the stoma adapter 20 a reduced overall diameter. Afterinsertion, the fluted cross-section is expanded to its final circularshape 96.

Expansion of the collapsed configuration after introduction of theproximal end 22 into the stoma 10 could be accomplished by means of amandrel (not shown) which could be inserted into the stoma adapter 20and then expanded to initiate the shape change. Such a mandrel could bemechanical in nature, but a desirable embodiment may be an inflatablecylinder which could be inflated to the appropriate diameter to expandthe stoma adapter 20 to its final shape. In another embodiment, elementsmade of a shape-memory material expand after introduction and exposureto body temperature, causing the stoma adapter 20 to expand to its finalshape.

Referring to FIG. 17, if the stoma adapter 20 is non-rigid or flexible,at least in the axial direction (e.g., as in the embodiments of FIGS.14A, 14B, 15B and 15C when not inflated), it may be desirable to employan insertion device 100 to aid insertion of the proximal end 22 into thestoma 10. To improve ease of insertion, the cross section of the stomaadapter 20 is preferably reduced or minimized, especially at theproximal end 22. This is accomplished by selectively folding andpleating the flexible material of the stoma adapter 20 into a crosssection size and shape that is more easily introduced into the bowel.Once introduced, the material of the stoma adapter 20 may be unfoldedand deployed by mechanical means or pneumatic means, for example usingthe same component as the insertion device 100, or using a differentcomponent (not shown). If required, the insertion device 100 used toassist in the introduction of the stoma adapter 20 into the bowel couldbe removed.

The stoma adapter 20 may be held captive in its folded state by aconstricting element 102 that can be removed or released afterintroduction into the stoma 10. The constricting element 102 may bearranged at the proximal end 22 of the stoma adapter 20.

Referring to FIG. 18, one form of such a constricting element 102 may bemade of biocompatible material that dissolves or is absorbed shortlyafter introduction of the stoma adapter 20 into the stoma 10. Forexample, the constricting element 102 may dissolve upon contact withstomal fluid. In the illustrated form, the constricting element 102 is atightly-formed band or collar made of the biocompatible material.

Referring to FIGS. 19A and 19B, in another embodiment the constrictingelement 102 is in the form of a conical tip for holding the stomaadapter 20 in its folded state. The cone could be formed from adissolvable material, as described above. Additionally or alternatively,an insertion device 100 may be employed to introduce stoma adapter 20and dislodge the constricting element (conical tip) 102. For example,the constricting element (conical tip) 102 may be dislodged when thestoma adapter 20 reaches its fully inserted position, and theconstricting element (conical tip) 102 then bears the full insertionforce applied through the insertion device 100. The insertion device 100would then be withdrawn through the distal end 24 of the stoma adapter20.

Materials for these constricting elements 102 include, but are notlimited to, biocompatible materials of natural or synthetic origin suchas polysaccharides, cellulosics such as hydroxypropylmethyl cellulose,hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethylcellulose, chitosan and its derivatives, gelatin, alginates, sodiumalginate, xanthan gum, tragacantha, guar gum, acacia gum, arabic gum,polyacrylic acid and its copolymers, polypeptides, sulfonated polymers,polyacrylamide and its copolymers, polyvinyl pyrrolidone, polyvinylether, polyvinyl alcohol, polyethylene, glycol, x, methylmethacrylatecopolymers, and carboxyvinyl polymers and copolymers.

Referring to FIGS. 20A, 20B and 20C, in another embodiment, the stomaadapter 20 could be partially inverted into a folded shape (FIG. 20A)and its proximal end 22 temporarily closed with a constricting elementor tip 102. In use, the stoma adapter 20 in its inverted condition ispartially introduced into the stoma 10 (FIG. 20A), and then a moderateamount of air or saline is applied from a pressurization source 104 topressurize the distal end of the stoma adapter. As illustrated in FIGS.20B and 20C, the pressure causes the stoma adapter 20 to unfold, andthus introduce the proximal end 22 into the bowel as the stoma adapter20 unfolds.

It will be appreciated that the stoma adapter of the present inventioncan provide effluent guidance and skin protection for all types ofstoma, but is especially suitable for recessed or flush stomas, whichare difficult to manage. The stoma adapter may be independent of theostomy appliance with which it is used, or the stoma adapter may beattachable to the ostomy appliance or an integral part of the ostomyappliance. The stoma adapter may take many different rigid or non-rigidforms, depending on the desired characteristics.

Many modifications may be made to the preferred embodiments used withoutdeparting from the claim coverage of the invention.

The invention claimed is:
 1. A stoma adapter comprising: a substantiallyunobstructed tubular passageway for expulsion of effluent with aproximal end for attachment in or around a stoma and a distal end fordischarge of waste, the distal end comprising a flange, a flexibletubular wall surrounding said entire tubular passageway, said flexibletubular wall having at least one axial reinforcement element forreinforcing said flexible tubular wall in an axial direction to provideaxial stiffness along the entire tubular passageway and permit flexingof the flexible tubular wall in a radial direction, and a one-way valve,wherein the one-way valve prevents re-entry of discharged waste into thedistal end of the tubular passageway, wherein the one-way valve isopenable from a closed position by pressure of the effluent when a bowelforces the expulsion of the effluent, wherein the one-way valve isdisposed at the distal end.
 2. The stoma adapter of claim 1 wherein atleast one reinforcement element is inflatable.
 3. The stoma adapter ofclaim 1 wherein at least one reinforcement element is a helicalcompression spring.
 4. The stoma adapter of claim 3 wherein the helicalcompression spring is formed from metal.
 5. The stoma adapter of claim 3wherein the helical compression spring is formed from polymer.
 6. Thestoma adapter of claim 3 wherein the helical compression spring isformed from a flexible and inflatable tube with a helical shape.
 7. Thestoma adapter of claim 1 wherein the flange releasably or permanentlyengages the stoma adapter to a body fitment attached to an ostomy pouch.8. The stoma adapter of claim 7 wherein the body fitment is secured to asubject's periostomal skin by an adhesive attachment.
 9. The stomaadapter of claim 8 wherein the body fitment is secured to a subject'speriostomal skin.
 10. The stoma adapter of claim 7 wherein the flange isattached to the body fitment by a mechanical fastener.
 11. The stomaadapter of claim 7 wherein the flange is attached to the body fitment byan adhesive attachment.
 12. The stoma adapter of claim 7 wherein theflange is trapped between the periostomal skin and the body fitment tohold the stoma adapter in position.
 13. The stoma adapter of claim 7wherein the stoma adapter provides direct transport of effluent from thebowel into an ostomy pouch attached to the body fitment.
 14. The stomaadapter of claim 1, wherein the axial reinforcement element spans theentire length of the stoma adapter.